Avalide may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor if you have any symptoms of dehydration or mineral loss including extreme thirst, very dry mouth, muscle cramps, irregular heartbeat, confusion, and decreased urination. Tell your doctor if you have unlikely but serious side effects of Avalide including:

symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat), or

an unusual change in the amount of urine (not including the normal increase in urine when you first start Avalide).

The usual dose of Avalide is 150mg/12.5mg to 300mg/25mg once a day. Drug interactions of Avalide include
Propulsid (cisapride), corticosteroids (for example, prednisone), methenamine, quinidine, Eskalith, Lithobid (lithium) and probenecid. Avalide should not be used during pregnancy as it may cause adverse effects in the fetus. The safety of taking Avalide in breastfeeding mothers has not been determined.

Our Avalide Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, this medicine can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice. The adverse reaction
information from clinical trials does, however, provide a basis for identifying
the adverse events that appear to be related to drug use and for approximating
rates.

Irbesartan-Hydrochlorothiazide

AVALIDE tablets have been evaluated for safety in 1694
patients treated for essential hypertension in 6 clinical trials. In Studies I
through IV with AVALIDE, no adverse events peculiar to this combination drug
product have been observed. Adverse events have been limited to those that were
reported previously with irbesartan or hydrochlorothiazide (HCTZ). The overall
incidence of adverse events was similar with the combination and placebo. In
general, treatment with AVALIDE was well tolerated. For the most part, adverse
events have been mild and transient in nature and have not required discontinuation
of therapy. In controlled clinical trials, discontinuation of AVALIDE therapy
due to clinical adverse events was required in only 3.6%. This incidence was
significantly less (p=0.023) than the 6.8% of patients treated with placebo who
discontinued therapy.

In these double-blind controlled clinical trials, the
following adverse events reported with AVALIDE occurred in ≥1% of
patients, and more often on the irbesartan-hydrochlorothiazide combination than
on placebo, regardless of drug relationship:

Irbesartan/ HCTZ
(n=898) (%)

Placebo
(n=236) (%)

Irbesartan
(n=400) (%)

HCTZ
(n=380) (%)

Body as a Whole

Chest Pain

2

1

2

2

Fatigue

6

3

4

3

Influenza

3

1

2

2

Cardiovascular

Edema

3

3

2

2

Tachycardia

1

0

1

1

Gastrointestinal

Abdominal Pain

2

1

2

2

Dyspepsia/heartburn

2

1

0

2

Nausea/vomiting

3

0

2

2

Immunology

Allergy

1

0

1

1

Musculoskeletal

Musculoskeletal Pain

6

5

6

10

Nervous System

Dizziness

8

4

6

5

Dizziness Orthostatic

1

0

1

1

Renal/Genitourinary

Abnormality Urination

2

1

1

2

The following adverse events were also reported at a rate
of 1% or greater, but were as, or more, common in the placebo group: headache,
sinus abnormality, cough, URI, pharyngitis, diarrhea, rhinitis, urinary tract
infection, rash, anxiety/nervousness, and muscle cramp.

Adverse events occurred at about the same rates in men
and women, older and younger patients, and black and non-black patients.

Adverse events in Studies V and VI were similar to those
described above in Studies I through IV.

Irbesartan

Other adverse events that have been reported with
irbesartan, without regard to causality, are listed below:

Initial Therapy

In the moderate hypertension Study V (mean SeDBP between
90 and 110 mmHg), the types and incidences of adverse events reported for
patients treated with AVALIDE were similar to the adverse event profile in
patients on initial irbesartan or HCTZ monotherapy. There were no reported
events of syncope in the AVALIDE treatment group and there was one reported
event in the HCTZ treatment group. The incidences of pre-specified adverse
events on AVALIDE, irbesartan, and HCTZ, respectively, were: 0.9%, 0%, and 0%
for hypotension; 3.0%, 3.8%, and 1.0% for dizziness; 5.5%, 3.8%, and 4.8% for
headache; 1.2%, 0%, and 1.0% for hyperkalemia; and 0.9%, 0%, and 0% for hypokalemia.
The rates of discontinuation due to adverse events on AVALIDE, irbesartan alone,
and HCTZ alone were 6.7%, 3.8%, and 4.8%.

In the severe hypertension (SeDBP ≥110 mmHg) Study
VI, the overall pattern of adverse events reported through 7 weeks of follow-up
was similar in patients treated with AVALIDE as initial therapy and in patients
treated with irbesartan as initial therapy. The incidences of the pre-specified
adverse events on AVALIDE and irbesartan, respectively, were: 0% and 0% for
syncope; 0.6% and 0% for hypotension; 3.6% and 4.0% for dizziness; 4.3% and
6.6% for headache; 0.2% and 0% for hyperkalemia; and 0.6% and 0.4% for
hypokalemia. The rates of discontinuation due to adverse events were 2.1% and
2.2%. [See Clinical Studies]

Postmarketing Experience

The following adverse reactions have been identified
during postapproval use of AVALIDE. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.
Decisions to include these reactions in labeling are typically based on one or
more of the following factors: (1) seriousness of the reaction, (2) frequency
of reporting, or (3) strength of causal connection to AVALIDE.

The following have been very rarely reported with
irbesartan and hydrochlorothiazide monotherapies: urticaria, jaundice,
hepatitis, thrombocytopenia, and impaired renal function including renal
failure.

The following have been reported with irbesartan
monotherapy: tinnitus, hyperkalemia, angioedema (involving swelling of the
face, lips, pharynx, and/or tongue), anaphylactic reaction including anaphylactic
shock, and increased CPK.

The following have been reported with hydrochlorothiazide
monotherapy: secondary acute angleclosure glaucoma and/or acute myopia.

Laboratory Abnormalities

In controlled clinical trials, clinically important
changes in standard laboratory parameters were rarely associated with
administration of AVALIDE.

Creatinine, Blood Urea Nitrogen

Minor increases in blood urea nitrogen (BUN) or serum
creatinine were observed in 2.3% and 1.1%, respectively, of patients with
essential hypertension treated with AVALIDE alone. No patient discontinued
taking AVALIDE due to increased BUN. One patient discontinued taking AVALIDE
due to a minor increase in serum creatinine.

Liver Function Tests

Occasional elevations of liver enzymes and/or serum
bilirubin have occurred. In patients with essential hypertension treated with
AVALIDE alone, one patient was discontinued due to elevated liver enzymes.